A Multi-Institution Study of TGFβ Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination With Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Pediatric Bone and Soft Tissue (NCT05634369)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to determine if the addition of infusions of a type of immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies. The goals of this study are: * To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGFβ imprinted (TGFβi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma. * To identify toxicities related to treatment with GEM/DOX + TGFβi expanded NK cells Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles. * Gemcitabine (GEM): via IV on Days 1 and 8 * Docetaxel (DOX): via IV on Day 8 * Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction * Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given * TGFβi NK cells: via IV on Day 12
Who can join: Review the eligibility criteria below.
Location: University of Alabama — South Birmingham, Alabama
Age range: 2 Years to 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- University of Alabama — South Birmingham, Alabama
- Phoenix Children's Hospital — Phoenix, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- Children's Hospital of Los Angeles — Los Angeles, California
- Stanford University — Palo Alto, California
- University of Florida — Gainesville, Florida
- Nemours Jacksonville — Jacksonville, Florida
- University of Miami — Miami, Florida
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida
- Washington University/St Louis Childrens — St Louis, Missouri
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- Montefiore Medical Center — The Bronx, New York
- University of North Carolina — Chapel Hill, North Carolina
- Levine Cancer Institute — Charlotte, North Carolina
- Duke Children's Hospital/Duke Health — Durham, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- UT Southwestern — Dallas, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas
- Primary Children's Hospital — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (813) 745-6250
Email: jessica.crimella@moffitt.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Pediatric Sarcoma, Refractory clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.